a single dose study of the pharmacokinetics of vibegron (mk-4618) in participants with renal insufficiency (mk-4618-014)

Conditions: Overactive Bladder

Summary: this study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (mk-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal impairment.


Eligibility criteria:
inclusion criteria - renal impaired patients * body mass index (bmi) ≤40 kg/m\^2 * clinical diagnosis of renal insufficiency * stable baseline health inclusion criteria - healthy subjects - stable baseline health exclusion criteria - renal impaired patients * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary disease * history of recent stroke, chronic seizures, or major neurological disorder * demonstrated or suspected renal artery stenosis * renal transplant or nephrectomy * history of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening * history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of study drug, throughout the study, and until the post study visit * unable to avoid taking diuretics within 4 hours prior to dosing and 4 hours post dosing; must be on a stable dose for at least approximately 2 weeks (or 5 half-lives of the compound, whichever is longer) * unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post-study visit * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day * major surgery, donation or loss of 1 unit of blood (approximately 500 ml) within 4 weeks prior to administration of study drug * plasma donation within 7 days prior to administration of study drug * current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months * nursing mother * participation in another investigational study within 4 weeks of study enrollment exclusion criteria - healthy subjects * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of stroke, chronic seizures, or major neurological disorder * history of cancer excepting certain skin or cervical cancers or cancers that were successfully treated 10 or more years prior to screening * history of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * unable to refrain from or anticipates the use of any medication including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the dose of study drug, throughout the study, until the post study visit * unwilling to refrain from consuming any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), and charbroiled meats 2 weeks prior to dosing until the post study visit * consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day * major surgery, donation or loss of 1 unit of blood (approximately 500 ml) within 4 weeks prior to administration of study drug * plasma donation within 7 days prior to administration of study drug * current regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months * nursing mother * participation in another investigational study within 4 weeks of study enrollment